Tioga Pharmaceuticals Issued Key U.S. Patent for the Use of Asimadoline to Treat D-IBS

June 16, 2011

SAN DIEGO, June 16, 2011 /PRNewswire/ — Tioga Pharmaceuticals, Inc. announced today that the United States Patent and Trademark Office (USPTO) has issued Patent No.7,960,429 “KAPPA-OPIATE AGONISTS FOR THE TREATMENT OF DIARRHEA-PREDOMINANT IRRITABLE BOWEL SYNDROME.” This patent covers the use of asimadoline to treat diarrhea predominant irritable bowel syndrome (D-IBS) and has an expiration date in June, 2028. The recently issued patent is owned by Tioga Pharmaceuticals. A continuation of this patent is currently on file with the USPTO.

“This patent augments the extensive asimadoline patent estate and covers the use of asimadoline for the treatment of diarrhea predominant irritable bowel syndrome. The patent will provide market exclusivity in the United States into June of 2028 and potentially beyond with patent term extension,” said David Urso, Chief Operating Officer and General Counsel of Tioga Pharmaceuticals.

Tioga is conducting a multi-center Phase 3 clinical trial evaluating asimadoline in D-IBS under a Special Protocol Assessment agreement with the FDA for U.S. registration. FDA has granted asimadoline Fast Track designation for the treatment of D-IBS. D-IBS is a common, chronic gastrointestinal disorder characterized by recurrent episodes of abdominal pain and diarrhea.

Asimadoline is an orally administered small molecule that is a highly selective, peripherally restricted, kappa opioid receptor agonist. In a 596-subject Phase 2b clinical trial asimadoline demonstrated statistically significant results in the treatment of D-IBS patients with at least moderate pain across multiple parameters including endpoints of pain, urgency, frequency and bloating in both males and females. A therapeutic benefit was observed within the first month of treatment and was sustained for the three-month duration of the trial. Asimadoline appeared to be well tolerated with no adverse events occurring in a dose-dependent manner throughout the randomized, double-blind, placebo-controlled, dose-ranging clinical trial. Asimadoline has been tested in over 1,100 subjects to date and has a positive safety profile.

About Tioga Pharmaceuticals

Tioga Pharmaceuticals, Inc. is a pharmaceutical company headquartered in San Diego, CA focused on developing novel treatments for gastrointestinal diseases. Tioga is developing asimadoline in Phase 3 clinical trials for the treatment of diarrhea-predominant irritable bowel syndrome (D-IBS). Ono Pharmaceutical Co, Ltd. licensed from Tioga exclusive rights to develop and commercialize asimadoline in Japan, where Phase 1 trials are currently underway, as well as South Korea and Taiwan. For more information about Tioga Pharmaceuticals, please visit www.tiogapharma.com.